EDF Health

Selected tag(s): Significant New Use Rule (SNUR)

Trump EPA caves again to industry demands on new chemicals, and workers pay the price

Richard Denison, Ph.D.is a Lead Senior Scientist.

Isocyanates are nasty chemicals, including when they are left over as residuals after manufacturing other chemicals.  Here are the kinds of risks they pose, according to the National Institute for Occupational Safety and Health (NIOSH):

Isocyanates are powerful irritants to the mucous membranes of the eyes and gastrointestinal and respiratory tracts.  Direct skin contact can also cause marked inflammation.  Isocyanates can also sensitize workers, making them subject to severe asthma attacks if they are exposed again. There is evidence that both respiratory and dermal exposures can lead to sensitization.  Death from severe asthma in some sensitized subjects has been reported.

In prior reviews of new chemicals under the Toxic Substances Control Act, EPA has repeatedly indicated that “[i]socyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent.”

Both NIOSH and EPA have raised even greater concern over activities involving spray application of chemicals containing isocyanates.  In 2006, NIOSH issued a rare alert calling for workers to undergo medical surveillance and wear high-efficiency respirators and gloves when engaged in such activities.

Even in the recent past, when reviewing new chemicals containing isocyanate residuals, EPA has typically (1) issued a consent order subjecting the company submitting the chemical for review to multiple conditions in order to limit workplace inhalation exposures to the residuals, and (2) followed up with a Significant New Use Rule (SNUR) that extends those conditions to other companies, requiring them to notify EPA prior to engaging in any activity that exceeds those workplace limits.  And the only case since TSCA was amended in 2016 where EPA found a new chemical “presents an unreasonable risk” – as opposed to the more common, lower-bar finding that it “may present an unreasonable risk” – involved residual isocyanates present after manufacture of two new chemicals.

In such cases EPA has imposed some combination of three types of conditions on manufacture of such chemicals:  prohibitions on activities that could generate inhalable forms of the chemical and result in inhalation exposures; strict requirements for the use of high-efficiency respirators and gloves; and a strict limit on the amount of isocyanate residuals allowed to be present in the new chemical, typically in the range of 0.1% to 0.2%.

So it is quite disturbing to see how EPA has dealt with the most recent such new chemical for which EPA has issued its final decision – which requires that companies employ NONE of these protections.  Read More »

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PART 1: Busting industry-perpetrated myths about new chemicals and worker protection under TSCA

Richard Denison, Ph.D.is a Lead Senior Scientist.

Part 1          Part 2         Part 3

This week the House Energy & Commerce Committee held a hearing on EPA’s failures to protect workers from chemical risks.  It featured a number of compelling testimonies from worker representatives:  auto workers, firefighters, teachers, and farmworkers.  It also featured testimony from a former Occupational Safety and Health Administration (OSHA) official, who made the case for why it is so critical that the Environmental Protection Agency (EPA) comply with the mandates and use the enhanced authorities Congress gave the agency under the Toxic Substances Control Act (TSCA) to protect workers exposed to chemicals.  He detailed why OSHA is unable to do so, describing OSHA as “outmatched” and having “exhausted its capacity” in the face of decades of severe budget cuts and limited legal authority.

The chemical industry is perpetuating damaging myths about worker protection at EPA and OSHA, which have unfortunately taken a firm hold in the Trump EPA.

Unfortunately, the hearing also included testimonies from two chemical industry representatives who painted a highly deceptive picture of what EPA has done to protect workers under the new TSCA and the adequacy of OSHA regulations regarding chemical risks in the workplace and the extent of compliance with them.  This and future posts will address the damaging myths these witnesses are perpetuating, which have unfortunately taken a firm hold in the Trump EPA.

Myth #1:  EPA is committed to protecting workers when reviewing new chemicals under TSCA.   Read More »

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Need more evidence of the chemical industry’s bad faith on TSCA? Read this.

Richard Denison, Ph.D.is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

This story is about chemicals known as chlorinated paraffins.  They are used as flame retardants, plasticizers and lubricants, among other things.  They come in three main versions:  short, medium, and long-chain.  Short-chain chlorinated paraffins (SCCPs) have been banned or are set to be banned in a number of jurisdictions and are listed for elimination under the Stockholm Convention.  The U.S. is not a party to Stockholm and has not banned SCCPs.  However, in 2012 EPA secured agreement from their leading domestic manufacturer, Dover Chemical Corporation, and their leading importer, INOVYN (formerly INEOS Chlor Americas, Inc.), to phase them out in consent decrees issued to settle enforcement actions EPA had brought against the companies (more on that later).

Concern over the medium and long-chain variants (MCCPs and LCCPs) has been significant and growing, however.  This is because they, like SCCPs, are expected to be very persistent and very bioaccumulative (vPvB) and, given evidence of systemic toxicity as well as toxicity to aquatic and terrestrial organisms, are also expected to be PBTs (persistent, bioaccumulative, and toxic chemicals).

The regulatory history of chlorinated paraffins under TSCA has been long and taken numerous, often troubling, turns.  We’ll only touch on some highlights here.   Read More »

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Have we learned anything in the last 4 decades when it comes to allowing chemicals like PCBs onto the market?

Richard Denison, Ph.D.is a Lead Senior Scientist.  Stephanie Schwarz, J.D., is a Legal Fellow.

The Science section of today’s New York Times reports “Killer Whales Face Dire PCBs Threat” – more than four decades after Congress largely banned PCBs (polychlorinated biphenyls).

Concentrations of the chemicals in the blubber of orcas living in waters off the coasts of industrialized countries remain high, and new research indicates the contamination presents an existential threat to the survival of these populations.

Reading the article brought to mind concerns we have raised in recent comments to EPA on proposed rules it has issued for new chemicals under the Toxic Substances Control Act (TSCA).  Read More »

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The TSCA new chemicals mess: A problem of the chemical industry’s own making

Richard Denison, Ph.D.is a Lead Senior Scientist.

Nary a day goes by without a complaint being lodged by someone in the chemical industry, or in one of the myriad law firms that represent its interests in Washington, D.C., about the delays in EPA’s approval of new chemicals under the Toxic Substances Control Act (TSCA).

Here’s the irony:  Those delays and the general chaos in the TSCA new chemicals program are entirely of the industry’s own making.   Read More »

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EPA needs to get its SNURs in order under TSCA

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D.is a Lead Senior Scientist.

On Friday EDF submitted comments to EPA on a batch of Significant New Use Rules (SNURs) the Environmental Protection Agency (EPA) published on August 1 pursuant to the Toxic Substances Control Act (TSCA).

The SNURs relate to 145 new chemicals for which EPA had earlier issued consent orders that imposed certain conditions on the substances.  Those consent orders date back to when EPA was still pursuing the development of such orders for many new chemicals it reviewed, and prior to the recent “pivots” it has been making in an effort to avoid issuing orders by circumventing the requirements of the TSCA provisions governing new chemicals.

TSCA anticipates that EPA will promulgate SNURs to follow up on consent orders.  In fact, TSCA section 5(f)(4) requires that when EPA issues an order, EPA must either promulgate a SNUR or provide a statement explaining why EPA is not doing so.  And when EPA does promulgate such a SNUR, the SNUR must “identif[y] as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the … order.”

EDF strongly supports EPA’s use of SNURs to follow up on consent orders it issues.  That is because the order only applies to the original company that submitted a premanufacture notice (PMN) to EPA for a new chemical.  A proper SNUR then requires that company or any other company that seeks to deviate from the conditions in the order to first notify EPA, triggering a review of that “significant new use.”

While EDF supports EPA’s issuance of SNURs for these 145 new chemicals, our review of the proposed SNURs raised concerns, prompting us to file “adverse” comments.  Our comments raise two major concerns:

First, EPA has adopted an ad hoc testing policy in the direct final rule that does not comply with the requirements of TSCA, without sufficient explanation, and without providing any notice and opportunity for public comment on the policy. EPA needs to avoid adopting such an ad hoc policy.

Second, as noted above, TSCA (as well as EPA’s longstanding policy) requires SNURs to “conform” to the restrictions in the corresponding orders.  Yet we identified numerous inconsistencies between the orders and SNURs.  EPA must ensure that the final SNURs identify as a significant new use any activity that is not consistent with the restrictions in the corresponding consent orders.

See our comments for details.

NOTE:  EPA had published the SNURs both as a direct final rule and as a proposed rule, noting that if it received any adverse comments, it would withdraw the direct final rule and consider the comments received in the process of finalizing the proposed rule.  We expect EPA will now pursue this course.

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